What is the relative safety of dabigatran and vitamin K antagonists (VKAs)?

Included studies compared dabigatran, 150 mg twice daily, with VKAs alone or low-molecular weight heparin in adults ≥ 18 years of age, and had a treatment duration ≥ 90 days. Outcomes included mortality, major bleeding, and all bleeding.

MEDLINE, EMBASE/Excerpta Medica, and Cochrane Library (all to Jun 2013) were searched for randomized controlled trials (RCTs) published in English or French. Reference lists were also searched. 5 multicenter RCTs (n = 20 332, mean age 55 to 71 y), ranging in size from 502 to 18 113 patients, met the selection criteria. 1 RCT comprised patients from 2 other trials included in the review and was excluded from meta-analyses. The remaining 4 RCTs, which included patients treated for atrial fibrillation (AF) (n = 12 334) or venous thromboembolism (VTE) (n = 5132), ranged in size from 236 to 12 098 patients and had follow-up of 84 to 730 days. All trials had low risk for bias as defined by the Cochrane risk for bias tool.